Intelligent endoscope systems and methods

ABSTRACT

Endoscope sheaths and associated endoscopy data collection and analysis systems and methods are described. In one implementation an endoscope sheath include a body and one or more sensors disposed in the body. The sheath may further include a leak detection apparatus configured to detect leaks in the sheath body. In addition, the sheath may include actuator apparatus, such as a balloon catheter or other surgical instrument. Data from the endoscope and endoscope sheath may be collected, fused and displayed for use in medical procedures and/or analysis.

FIELD OF THE INVENTION

The present invention relates generally to endoscopy and endoscopesheaths. More particularly but not exclusively, the invention relates toendoscopy sheath apparatus and methods aided by sensors such aspressure, temperature, position detection sensors, leak detectionsensors, acoustic sensors and/or other types of sensors, as well asactuators such as balloon actuators, catheters and/or surgicalinstrument actuators.

BACKGROUND

Endoscopy has been used for a variety of diagnostic and surgicalprocedures in the medical field, as well as other non-medical fields,for many years. In a typical medical endoscopy procedure, an endoscope,which commonly includes a body having flexible and/or rigid structuralelements along with an imaging element such as a camera and/or lensassembly and lighting, is inserted into a body orifice such as the nose,throat, or rectum and is then positioned to view conditions inside thebody. Some endoscopes are configured in an ingestible pill form (denotedherein as “pill-type” endoscopes to distinguish them from traditionalendoscopes) that is swallowed and travels through the body whilecollecting diagnostic information.

In order to prevent introduction of germs or other foreign matter intothe body, endoscopes are frequently reprocessed using sterilizationequipment, disinfected in a germicidal solution or enclosed by a sheath,which is typically made of a pliable material which conforms to theshape of the endoscope body and isolates any contamination from theendoscope. Currently used endoscope sheaths are costly, one time usedisposable components that primarily act as passive covers for theendoscope, without providing any additional diagnostic functionality.Moreover, in many cases, endoscope sheaths may act to limit or inhibitendoscope functionality by imposing a barrier between the endoscope andthe patient's body part being examined. For example, componentsincorporated into the endoscope, such as imaging elements, may havereduced optical performance due to the sheath and condensation that mayoccur between the sheath and the endoscope lens. Sensor integral to theendoscope may also be rendered non-functional when covered by thesheath.

Problems with endoscope and sheath sterilization have received attentionfrom organizations such as the FDA and CDC, which have promulgatedpublications including “Guidance for Manufacturers Seeking MarketingClearance of Ear, Nose and Throat Endoscope Sheaths Used as ProtectiveBarriers,” at//www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073746.htm,“FDA and CDC PUBLIC HEALTH ADVISORY, Infections from EndoscopesInadequately Reprocessed by an Automated Endoscope Reprocessing System,”at http://www.olympusamerica.com/msg_section/files/FDAadvisory.pdf, “FDAPublic Health Notification: Updated Information on Customer Ultrasonics,Inc., Endoscope Washer/Disinfectant.” athttp://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/UCM062075.Concerns have led to investigations of the value of sheaths as barrierfunctions for endoscopy, see, e.g., EVALUATION OF PROTOCOLS FOR TESTINGENDOSCOPE SHEATHS AS VIRAL BARRIERS, Baker, et al., FDA Science Forum,1997, which is incorporated by reference herein.

While sheaths have been used for some time in endoscopy, they have notbeen used to provide other sensory inputs or actuator functions toimprove diagnosis and treatment. Accordingly, there is a need in the artfor improved endoscope sheaths, as well as associated medicaldiagnostic, analytic and treatment techniques.

SUMMARY

The present invention is directed generally towards endoscope sheathsand endoscopy systems and methods.

In one aspect, the present invention relates to an endoscope sheathcomprising a body and one or more sensor elements. The sheath mayinclude a leak detection apparatus and/or an integral actuatorapparatus.

In another aspect, the present invention relates to an endoscope sheath,comprising a body including an exterior surface, an interior surface anda cavity bounded by the interior surface, the cavity disposed forreceiving an endoscope and one or more sensors disposed in the body.

In another aspect, the present invention relates to an endoscope sheath,comprising a body including an exterior surface, an interior surface anda cavity bounded by the interior surface, the cavity disposed forreceiving an endoscope and a leak detection apparatus configured todetect a leak in the body.

In another aspect, the present invention relates to an endoscope sheath,comprising a body including an exterior surface, an interior surface anda cavity bounded by the interior surface, the cavity disposed forreceiving an endoscope; and an actuator apparatus disposed in the sheathbody.

In another aspect, the present invention relates to a system forperforming endoscopy, comprising an endoscopy sheath, said endoscopesheath including one or more sensors and an endoscopy analysis module,said analysis module including: a processor, a memory coupled to theprocessor and an input module coupled to the processor, wherein theprocessor is configured to: receive data from the one or more sensors,receive data from an endoscope coupled to the analysis module, fuse thedata from the one or more sensors and the data from an endoscope andstored the fused data in the memory.

In another aspect, the present invention is related to a machinereadable medium containing instructions for execution by a computer toreceive data from one or more sensors disposed on an endoscope sheath,receive data from an endoscope, fuse the data from the one or moresensors and the data from an endoscope and stored the fused data in amemory.

In another aspect, the present invention is related to a method ofperforming an endoscopy procedure, comprising generating sensor datafrom a body cavity of a patient, wherein the sensor data is providedfrom one or more sensors disposed on an endoscope sheath positioned onan endoscope and providing the sensor data to a endoscopy analysismodule.

Additional aspects of the present invention are described below inconjunction with the appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the nature and objects of variousembodiments of the invention, reference should be made to the followingdetailed description taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1 illustrates an example endoscope and associated endoscope sheath;

FIG. 2A illustrates one embodiment of an endoscope sheath including anintegrated sensor element in accordance with aspects of the presentinvention;

FIG. 2B illustrates one embodiment of a cross-section of an endoscopesheath as shown in FIG. 2A, in accordance with aspects of the presentinvention;

FIG. 2C illustrates another embodiment of a cross-section of anendoscope sheath as shown in FIG. 2A, in accordance with aspects of thepresent invention;

FIG. 2D illustrates one embodiment of a connector configuration for anendoscope sheath, in accordance with aspects of the present invention;

FIG. 2E illustrates one embodiment of a sensor element for an endoscope,in accordance with aspects of the present invention;

FIGS. 3A-3C illustrate various embodiments of an endoscope sheathincluding a plurality of sensor elements, in accordance with aspects ofthe present invention;

FIG. 3D illustrates one embodiment of a position sensing detector, inaccordance with aspects of the present invention;

FIG. 4A illustrates one embodiment of an endoscope sheath heatingelement configuration in accordance with one aspect of the presentinvention;

FIG. 4B illustrates one cross sectional view of an endoscope sheathheating element configuration in accordance with one aspect of thepresent invention;

FIG. 5A illustrates one embodiment of a sensor enhanced endoscopy systemin accordance with aspects of the present invention;

FIG. 5B illustrates one embodiment of a processing system for sensorenhanced endoscopy in accordance with aspects of the present invention;

FIG. 6A illustrates an endoscopy system including a position locationelement in accordance with aspects of the present invention;

FIG. 6B illustrates one embodiment of an endoscope sheath withultrasonic measurement apparatus, in accordance with aspects of thepresent invention;

FIG. 7 illustrates one embodiment of a method of using a sensor enhancedendoscopy system in accordance with aspects of the present invention;

FIG. 8 illustrates details of an embodiment of an electronics module foruse in processing data and information received from an endoscope andsmart sheath;

FIGS. 9A and 9B illustrate details of a cross-sectional sensor profileas may be generated by a smart sheath;

FIG. 10 illustrates an example of a leak in a smart sheath;

FIGS. 11A-11C illustrate details of an embodiment of a smart sheathincluding a leak detection apparatus;

FIGS. 12A-12C illustrate details of embodiments of electrical leakdetection details that may be used in conjunction with the sheath asshown in FIGS. 11A-11C;

FIG. 13 illustrates details of embodiments of pneumatic leak detectiondetails;

FIGS. 14A and 14B illustrate details of an embodiment of an endoscopesheath with integral actuator apparatus;

FIG. 15 illustrates details of an embodiment of an endoscope sheath withintegral actuator apparatus;

FIGS. 16A and 16B illustrate details of an embodiment of an endoscopesheath with integral actuator apparatus;

FIGS. 17A and 17B illustrate details of an embodiment of an endoscopesheath with integral actuator apparatus.

DETAILED DESCRIPTION OF EMBODIMENTS

The present invention is directed generally towards endoscope sheathsand endoscopy systems and methods.

In one aspect, the present invention relates to an endoscope sheathcomprising a body and one or more sensor elements. The sheath mayinclude a leak detection apparatus and/or an integral actuatorapparatus. In another aspect, the present invention relates to anendoscope sheath, comprising a body including an exterior surface, aninterior surface and a cavity bounded by the interior surface, thecavity disposed for receiving an endoscope and one or more sensorsdisposed in the body. In another aspect, the present invention relatesto an endoscope sheath, comprising a body including an exterior surface,an interior surface and a cavity bounded by the interior surface, thecavity disposed for receiving an endoscope and a leak detectionapparatus configured to detect a leak in the body.

In another aspect, the present invention relates to an endoscope sheath,comprising a body including an exterior surface, an interior surface anda cavity bounded by the interior surface, the cavity disposed forreceiving an endoscope; and an actuator apparatus disposed in the sheathbody. In another aspect, the present invention relates to a system forperforming endoscopy, comprising an endoscopy sheath, said endoscopesheath including one or more sensors and an endoscopy analysis module,said analysis module including: a processor, a memory coupled to theprocessor and an input module coupled to the processor, wherein theprocessor is configured to: receive data from the one or more sensors,receive data from an endoscope coupled to the analysis module, fuse thedata from the one or more sensors and the data from an endoscope andstored the fused data in the memory.

In another aspect, the present invention is related to a machinereadable medium containing instructions for execution by a computer toreceive data from one or more sensors disposed on an endoscope sheath,receive data from an endoscope, fuse the data from the one or moresensors and the data from an endoscope and stored the fused data in amemory. In another aspect, the present invention is related to a methodof performing an endoscopy procedure, comprising generating sensor datafrom a body cavity of a patient, wherein the sensor data is providedfrom one or more sensors disposed on an endoscope sheath positioned onan endoscope and providing the sensor data to a endoscopy analysismodule. Additional aspects are described below in conjunction with theappended drawings.

Various embodiments of the present invention may be implemented usingtechniques for detection and monitoring of fluid flow and/or pressure.Various aspects of implementations of such detection and monitoring aredescribed in U.S. Pat. Nos. 6,408,682, 6,412,334, 7,353,692 and5,008,616. The content of each of these patents is incorporated byreference herein in its entirety.

Endoscopy has been used in a variety of medical diagnostic and treatmentapplications to view details inside the body of a patient, as well asfor various other non-medical application. FIG. 1 illustrates asimplified view of a typical prior art endoscopy system 100 thatincludes an endoscope 110 and an endoscope sheath 120. Typicalendoscopes, such as endoscope 110, include a body having flexible and/orrigid mechanical structures for allowing the device to be inserted in anopening in the patient's body, such as the nose, mouth, rectum or anincision in the body, and then manipulated once inside the body to viewvarious internal features. A typical endoscope also includes a handleand other mechanical and electrical components (not shown), coupled atthe proximal end (not shown) of the instrument to facilitate insertionof the endoscope into the body and visualization of the area beingdiagnosed or treated.

The endoscope's visualization function may be facilitated by an imagingelement 102, such as a lens or camera element, positioned in the distalend 108 of the endoscope, which may be accompanied by a light emittingelement 104, such as a light source, LED, optical fiber, and the like,to illuminate the area of interest.

In addition, endoscopy system 100 may include an endoscope sheath 120.Endoscope sheath 120 is provided to facilitate prevention ofcontamination to a patient and/or endoscope, such as by cross-infectionthrough exchange of biological material between patients, as well as tomaintain endoscope sterilization by providing a physical barrier betweenthe endoscope 110 and the patient's body. A typical endoscope sheath isconfigured similar to a balloon or condom, including a body 121,typically comprising a thin, pliable material having an outer surfaceexposed to the patient's body and tissues, and an inner surface exposedto the endoscope. Endoscope sheath 120 is configured with a hollow innercavity or lumen 126 to facilitate receipt of the endoscope when insertedinto the sheath, a proximal end 128 configured to be positioned outsidethe patient's body during an endoscopic procedure, a distal end 122configured to be positioned adjacent to the corresponding distal end ofthe endoscope 110, and an optical port 124, configured to providetransparency and/or filtering to the imaging element 102 and/or lightemitting element 104 when the endoscope 110 is inserted into the sheath120. Endoscope sheaths are typically more costly to use than germicidalsolutions and are a disposable item, for one time use, with little to nofunctionality beyond isolating the exterior of the endoscope from directcontact with the patient.

Attention is now directed to FIG. 2A, which illustrates one embodimentof an endoscope sheath 220 in accordance with aspects of the presentinvention. As shown in FIG. 2A, an endoscope sheath may include a bodysimilar to that shown in FIG. 1, as well as one or more sensor elements230, as well as other elements (not shown in FIG. 2A), disposed in thesheath body to facilitate sensing of desired parameters or physicalconditions of interest during an endoscopy procedure. The sheath bodywill generally include an exterior surface and interior surface, withthe body typically formed to match and cover the associated endoscope insubstantially its entirety. However, in some embodiments, the sheathbody may be made so as to cover only part of the endoscope. In someimplementations, the sheath may be made so as to have openings at bothends, and may also include sealing mechanisms at one or both ends of thesheath body to seal the part of the endoscope that is enclosed. Otherbody shapes may be used in some embodiments, with the body shapeconfigured to accommodate one or more sensor elements such as arefurther described below.

In some implementations, the sheath body may comprise a flexible orsemi-flexible material. Body materials may comprise latex, nitrile,plastics, polymers, rubber materials or other materials known ordeveloped for use in medical applications. Likewise, for other endoscopyapplications, materials may be plastics, rubbers, polymers or othermaterials suitable for such applications, such as materials forcorrosive environments, contaminated environments, toxic environments,and the like. In some embodiments, the sheath body may comprise a rigidor substantially rigid material rather than a flexible material.

Sensor elements disposed in the sheath body may be configured so as toprovide sensing contact with a space exterior to the sheath, such as anairway between the sheath and a patient's throat or other body orifice,a blood vessel in a vascular implementations, or other body orificessuch as those in the digestive system or excretory system. In someimplementations, sensors may be disposed in the body so as to be incontact with a space interior to the sheath, such as a space between theinterior surface of the sheath and an inserted endoscope. Sensors may bedisposed in the body by attachment to the body on the interior orexterior, such as by use of adhesives or other attachment materials, bymolding or forming into the body, or by other attachment or formingmethods known or developed in the art.

Physical conditions of interest may include pressure, temperature, flowrate (based on, for example, flow of a gas such as air through an airwayor fluid, such as blood, through a flow channel such as an artery orvein), pH, cross-sectional distance measurements (such as measurement ofcross-sectional areas of a gas or liquid flow channel, such as the nasalpassages or throat), acoustic information (audible sounds or otheracoustic information), blood pressure, pulse, and the like.

In an exemplary embodiment, sensor element 230 comprises a pressuresensor, configured to measure pressure at or near a location beingimaged by the endoscope. Pressure sensor 230 may also include one ormore additional sensor elements. For example, in one embodiment, sensorelement 230 comprises a pressure sensor and temperature sensor, such asa MEMS based circuit like the SCP1000 device manufactured by VTITechnologies, which is configured to measure both pressure andtemperature at or near the location being imaged. Other similar orequivalent devices known or developed in the art may also be used invarious implementations.

Research and analysis by the inventors of the technology disclosedherein in the area of airway physiology and airflow characteristics hasshown a relationship between pressure values and airflow restrictions inbreathing channels, such as through airways like the nose, palate, andrear portion of the mouth and throat. These may be associated withconditions such as airway restriction and sleep apnea, or otherbreathing issues. While a conventional endoscope may provide somevisualization of an airway restriction, additional information of valuemay be added by acquiring pressure data, acoustic data, body conditionssuch as blood pressure, pulse, temperature and/or other sensor datasimultaneously with visual information such as images or video providedby the endoscope. In particular, it may be advantageous to obtain thisadditional sensory information and map or fuse it to the associatedimaging data obtained by the endoscope camera to provide an image ordisplay of the combined data and image or images in two or threedimensions.

In addition to pressure and/or temperature data, other data andinformation, such as the physical condition parameters described aboveor others, may be used in some embodiments to provide additionaldiagnostic and/or treatment information. For example, the sensor mayinclude an acoustic sensing element such as a microphone or otheracoustic sensing element to detect audible, sub-audible or ultrasonicsounds. The sensor may include a pH sensor, such as, for example, a pHsensor based on the National Semiconductor LMC6001 and shown in theassociated datasheet. Various other sensor elements as are known ordeveloped in the art may also be used in various embodiments.

Further, in addition to configurations of single sensors disposed in asheath body, two or three dimensional arrays of sensors may be desirableto generate sensory profiles over a surface, area or volume of thepatients body. For example, by using multiple pressure sensorsconfigured such as shown in the array configurations of FIG. 3A, 3B, 3C,or in other two dimensional or three dimensional configurations, flowrates and profiles may be determined over those areas, surfaces orvolumes. This enables a user such as a medical doctor to relate visualinformation to sensory data from the body region being diagnosed. Insome embodiments, images, pressure data, temperature data, acousticdata, and/or other data such as airflow rates, pH, and/or otherdiagnostic parameters, may be determined at a particular position withinthe body cavity being imaged and may then be mapped or fused together toprovide more comprehensive data and information for display and/oranalysis. In addition, information regarding airway dimensionalparameters as cross-sectional dimensions, area and/or volume may also beobtained through measurement sensing elements so at to add dimensionaldata to the diagnostic data. Dimensional measurements may be obtained byincorporating one or more ultrasonic, optical, mechanical and/or othermeasuring elements in the endoscope sheath, along with the other sensoryelements described above.

In some implementations, actuator apparatus may also be added to asheath. These may be inflatable actuator mechanisms such as ballooncatheters, or may be other actuator mechanisms such as scalpels,abrasion instruments, ultrasonic or acoustic elements, thermal (i.e.,heating or cooling elements), ablation instruments, stent placementinstruments, or other actuator apparatus known or developed in the art.In some cases, multiple actuator elements, such as a balloon catheter,surgical cutting tool such as a scalpel, or placement tool, such as ashunt placement tool, may be incorporated as actuator apparatus in thesheath. For example, in a vascular application, a sheath may include afirst actuator apparatus for deploying a balloon catheter and a secondactuator apparatus for placing a stent, basket or other embedded device.

Returning to FIG. 2A, As further shown, sheath 220 may include a channel232 for positioning sensor signal or data transmission apparatus, suchas signal wires, optical fibers or other means of transmitting sensorsignals and/or data. Channel 232 may also facilitate power transmissionto the sensor 230 from the endoscope 110 or a connector coupled to theendoscope 110 or a battery or external source, such as a power supply,battery, and the like. Sheath 220 may include an optical port 224, whichmay be configured as a clear port for providing viewing from an imagingelement of the endoscope, or may be a lens or other optical apparatusfor providing or enhancing imaging.

In addition, in some embodiments, sensor 230 may be configured tooperate via wireless transmission mechanisms, such as through radiofrequency (RF) signals, acoustic signaling, or other non-wired signalingtechniques, and the sensor may be battery powered or provided with powervia wiring in the sheath. Likewise, while sensor 230 may be powered bywires or batteries positioned in cavity 226 and/or channel 232, sensor230 may also be powered by scavenged power, such as may be providedthrough RF, acoustic, optical or other scavenged power mechanisms.

Sensor 230 will typically provide sensed signals and/or data via digitalor analog signaling mechanisms such as those known or developed in theart. For example, in one embodiment, sensor 230 is configured to providedigital data through a serial connection, such as an SPI serialinterface comprising conductors/wires 234, that can accommodate readingof one or more sensors through an electrical bus connector provided atthe proximal end of sheath 220 to be coupled to the endoscope 110 and/orexternal electronic devices, such as a signal recorder, display device,or other medical diagnostic instrument or data recorder. Sensor 230 mayalso provide one or more analog signals via wires 234 (or via othermechanisms, such as wireless transmission) to be processed and/ordisplayed by external electronic diagnostic or storage devices.Alternately, signaling may be done via nonelectrical connections 234,such as via optical fibers. As noted previously, connections 234 may bedisposed in channel 232 to facilitate smooth insertion of sheath 220 inan endoscope.

It is noted that, while shown on the outer surface of sheath 220 nearthe distal end, sensor element 230 need not be positioned only at thislocation, but may alternately be positioned at any of various positionsaround the circumference or longitudinal axis of sheath 220, asillustrated in FIG. 3. For example, in some embodiments sensor element230 may be positioned near the distal end of sheath 220 on the side (asshown in FIG. 2A), while in other embodiments the sensor element may bepositioned midway along the sheath (not shown in FIG. 2A), at the distalend adjacent to element 224 (not shown in FIG. 2A), or at otherpositions on or in sheath 220. In some embodiments, sensor element 230may be positioned on the end of the sheath 220, adjacent to or within anoptical port 224. In some cases, sensor element 230 may be placed on orwithin an actuator mechanism included in the sheath.

Sheath 220 may include one or more graduations disposed on or within thesheath body to facilitate position determination of the sheath during aprocedure. For example, the sheath may include graduations on theservice to identify the position of the sheath during a procedure viaultrasonic, electromagnetic, optic, or other measurement and positioningmechanisms. These may be painted or impregnated on or within the sheathbody using materials that may be imaged by x-rays, catscans, MRIs orother imaging technologies.

Sheath 220 may include one or more connectors 235 at or near theproximal end 228 to facilitate connection of the sensor elements to theendoscope handle, other endoscope electronics, processing components, orexternal devices (not shown). Connector 235 may comprise a singleconnector or a plurality of connectors with separate connections forsignal, power or other inputs or outputs. For example, FIG. 2Dillustrates one embodiment wherein one or more connectors 235 comprise apower connector 235 a configured to couple to a power supply or powerdevice such as battery 260. Alternately, the battery 260 may be mountedon or integral with the sheath 220. For example, the battery may beincorporated into a recess in the sheath or may be integrally formed inthe sheath for disposal after use. Other techniques known in the art forscavenging power, such as via chemical reactions within the body,photovoltaic power, and the like may also be used.

One or more additional signal connectors 235 b are also provided tocouple to one or more signal and/or data connections. It is furthernoted that signal connectors 235, 235 a and/or 235 b may be configuredto connect to additional connectors (such as an endoscope connectors)within the sheath 220 and/or externally from sheath 220 and may beincorporated into the sheath 220. Likewise, battery 260 (or other powersupply devices) may be incorporated into the endoscope or sheath 220 ormay be external to the endoscope and/or sheath 220.

Attention is now directed to FIG. 2B which illustrates one embodiment ofa cross section of a sheath 220. In this embodiment, the sensor element230 b is positioned on the external surface 221 of the sheath 220.Signal wires or other transmission mechanisms, such as thin filmconductive wires or other signaling mechanisms (if used), are thenrouted through the wall of the sheath to channel 232 b, which may bepositioned on the interior cavity 226 of the sheath, in proximity to theendoscope 110 when mounted in the sheath. Alternately, the sensorelement may be positioned all or partially within the sheath body, andthe signaling wires may be routed internal to or within the sheath body.

FIG. 2C illustrates an alternate embodiment of a cross section of asheath 220, which shows sensor element 230 c positioned inside of, orrecessed in a slot or other depression in the outer surface 221 of thesheath, or glued or affixed to the surface. Sensor 230 c may, forexample, be molded into sheath 220, or inserted into a recess in theouter surface 221 of the sheath. Wiring to the sensor, if used, may alsobe routed internal to the sheath, through a channel 232 c formed ormolded in the sheath. It is further noted that combinations of elementsas shown in FIG. 2B and FIG. 2C may also be used in various embodiments,and in some embodiments wherein wireless sensor information istransmitted, channel 232 may be omitted.

Attention is now directed to FIG. 3A which illustrates anotherembodiment of the present invention, wherein a plurality of sensors areprovided on or within an endoscope sheath 320. As shown in FIG. 3A,sensor elements 330 a through 330 n, where n is 2 or more, may bepositioned on or within sheath 320 to provide additional sensor data orsignals. Sensors 330 a through 330 n may comprise a plurality of aparticular type of sensor, such as a plurality of pressure/temperaturesensors as previously described, or sensor elements 330 a through 330 nmay comprise two or more different types of sensor elements configuredto sense different types of parameters. For example, one sensor element330 a may be configured to sense pressure and temperature, while anadjacent sensor element 330 b may be configured to sense temperature, pHand/or other parameters such as flow rate, dimensions, distance or otherposition information, or other parameters. It is further noted that,while shown in a linear configuration on sheath 320, sensor elements 330a through 330 n need not be positioned in this way (as shown in FIG.3A), and may be disposed around the circumference or longitudinal axisof sheath 320, and/or may be positioned in other ways, such as adjacentto each other around the circumference of the sheath 320, on or near theoptical port 224, or in other positioning arrangements such as gridarrays, depending on the desired sensing profile.

In addition to a plurality of sensor elements 230 a through 230 n,sheath 320 may also include one or more fiducials or targets 340 athrough 340 n, as shown in FIG. 3A, that are configured to provide amark or indication of the position of the endoscope, sheath, and/orsensor element(s) during an endoscopy procedure. For example, fiducials340 a through 340 n may comprise a reflective material, such as metalfoils or other reflective materials, that reflect/illuminate during anX-ray image, scan (such as a CAT scan), MRI, ultrasound, or during otherimaging processes that may be used in conjunction with the endoscopyprocedure. As such, targets 340 a through 340 n may then be used tomatch or fuse the data provided by sensors 330 a through 330 n withendoscopy images or visualizations, as well as with other images orvisualizations captured during the endoscopy procedure. It is also notedthat one or more targets 340 a through 340 n may be used in an endoscopesheath such as sheath 220 as shown in FIG. 2A, in conjunction with asingle sensor element 230, to facilitate identification of the positionof sensor element 230 during the endoscopy procedure.

In another embodiment, a touch sensor, such as a capacitive touchelement (not shown) may be incorporated in the endoscope sheath tofacilitate positional identification or registration during an endoscopyprocedure. For example, multiple capacitive elements may be incorporatedinto the endoscope sheath at fixed distances, and their capacitance maybe used to identify how deeply the endoscope has been positioned withinthe body cavity (such as an airway like the nasal passages or throat).

Attention is now directed to FIG. 3C, which illustrates details ofanother embodiment of the present invention. As shown in FIG. 3C, inaddition to, or in place of, one or more of the features as shown inFIGS. 3A and 3B, a sheath 320 c may include one or more positionlocation elements 342 a-342 n. These elements are typically disposed onthe endoscope sheath, or in some implementations the endoscope, tofacilitate position location and registration of the endoscope andsensors, relative to the patient's airways. In a representativeembodiment, element(s) 342 are a magnet configured to be used inconjunction with a Hall effect sensor such as the TLE4953 from InfineonTechnologies or the A1174 from Allegro Microsystems, Inc, or anothermagnetic sensing element, so that the position of the sheath relative tothe magnetic assembly can be detected by the magnetic sensing element.An example of this is further described below in conjunction with FIG.3D.

Attention is now directed to FIG. 3D which illustrates an embodiment ofa position sensing assembly 350, which may include a magnetic sensingelement such as Hall effect sensor in conjunction with a magnet, for usein determining the position of an endoscope during a procedure. As shownin FIG. 3D, position sensing assembly 350 (also denoted herein as a“position detector”) may be used to determine the position of theendoscope apparatus within the patient during an endoscopy procedure.This may be done by sensing magnetic transitions as the Hall effectsensor moves past each magnet and is counted or otherwise registered bya processor, such as a microcontroller. Thereby, position sensingdetector 350 is configured to locate, within the patient, the positionof the endoscope, and the position or positions of sensor elements suchas sensor 330 a of FIGS. 3A-3C and/or the imaging element/camera of theendoscope. The output of position detector 350 may be provided to anendoscopy analysis module, such as system 530 as shown in FIG. 5.Position information obtained in conjunction with position detector 350may then be used to fuse or map other sensory data, such as pressure,temperature, pH, airflow, etc., with an image or images of the airway ofthe patient and/or with other airway information, such as dimensions.This information may also be used to generate a cross-sectional or 3dimensional view or image of the patient, along with the associatedsensor information.

As shown in FIG. 3D, position sensing detector 350 may be used inconjunction with a magnet, fiducial, or other target mechanism disposedon the endoscope or on the endoscope sheath to map the endoscopeposition relative to the patient's body. In an embodiment based on aHall effect sensor, which uses a Hall effect device and a magnet tosense the presence of the magnet relative to the Hall effect device, theposition of the endoscope or particular endoscope sensors can bedetermined magnetically.

In one embodiment, position detector 350 includes a substrate 351,comprising a flexible plastic or other material, in which isincorporated a plurality of Hall effect sensors 352. The substrate 351may be configured with an adhesive or other material allowing temporaryattachment of the position detector 350 to the side of the patient'shead, as shown in FIG. 3D.

The number of Hall effect sensors 352 included in a particular positiondetector 350 sensor array may vary, depending on the size of thepatient, desired resolution, etc. For example, position detector 350includes 19 sensors 352 as shown in FIG. 3D; however, other numbers ofsensors may also be used. In addition, the array configuration of thesensors 252 may vary. For example, as shown in FIG. 3D, positiondetector 350 includes an array of sensors 252, with some sensors beingpositioned adjacent to the nasal passageway, some being positionedadjacent to the oral passageway, and some being positioned adjacent tothe throat. However, in other embodiments, the arrangement andpositioning of sensors may vary so as to provide sensing capabilitywithin a targeted portion of the desired airway or airways beingexamined. In one embodiment, a Hall effect sensor may be used and eitherdeployed in on the sheath or the reference strip. Multiple magnets wouldbe employed and spaced evenly along the strip. If a bipolar Hall effectsensor is used, each magnet may be alternately flipped from north tosouth. The mounting configuration of the magnets would be N S N S N S sothat the direction as well as the distance of movement relative to theHall effect sensor can be determined by the transition from north tosouth.

In operation, if a magnet is disposed on an endoscope sheath 320, suchas magnet 342 a of FIG. 3C (typically in the proximity of a sensor, suchas sensor 330 a, and/or the lens or imaging element of the endoscope andthe endoscope is inserted in a patient, the position of the magnet 342 arelative to the position detector 350 may be detected by determiningwhich Hall effect sensor or sensors are activated by the magnet. Thiswill occur when the magnet is in the vicinity of one or more of the Halleffect sensors 352, and the associated response can be mapped to aparticular position on the position detector 350, and correspondingly toa location on a patient.

Position detector 350 should preferably be matches or registered to thepatient so as to allow comparison of images and sensor data obtainedfrom the patient during the endoscopy procedure. This may beaccomplished by recording the location of the position detector 350relative to the patient by a photograph or other imaging techniquebefore, during or after the endoscopy procedure. Once the positiondetector 350 is registered to the patient, a map or other image of theposition of the endoscope within the patient may be generated, with themap including position information, an image or images of the airway,cross sectional dimensions, sensor data and/or other test or measurementparameters. This may be done in system 530, as further described herein.

Attention is now directed to FIG. 4A, which illustrates additionaldetails of one embodiment of an endoscope sheath in accordance withaspects of the present invention. As shown in FIG. 4A, an endoscopesheath may include one or more heating elements 410 configured to heatan area of the endoscope or sheath to improve performance. Theseelements may be, for example, a thin layer of indium tin oxide (ITO) orother resistive material that may be electrically driven to heat thedistal end of the sheath to reduce or eliminate moisture condensation orfogging. These heating elements may comprise resistive heating elementsas are known or developed in the art. The heating elements may bedisposed on the lens or lens area to improve visual clarity byalleviating condensation at the lens a cause of image blur. In oneembodiment, the heating element may comprise an ITO (indium tin oxide)coating through which a current may be run.

In addition, one or more temperature sensors may be used in combinationto implement closed loop control, where the internal temperature of theendoscope/sheath and/or lens or optical port area is regulated. This maybe done as follows; first, a measurement is made of the internaltemperature of the sheath, such as by using a temperature sensor mountedon the interior of the sheath and in contact with the endoscope or airpocket surrounding the endoscope. Then an external temperaturemeasurement of the body cavity outside the sheath is made, and theinternal and external temperatures compared. It is expected that theexternal temperature will typically be higher than the internaltemperature, so a heating element disposed on or in the sheath is thenenergized to heat the sheath and endoscope to a temperature that matchesor approximates the outside temperature (i.e., the body cavitytemperature). The temperature sensors and heating elements may becoupled with a closed-loop control system, such as are known in the art,to automatically implement this process of temperature matching. In someembodiments the closed-loop control system may be directly incorporatedin the sheath itself, in the form of a microcontroller or othermicrocircuit based implementation (such as on an FPGA, ASIC, etc.).

In other embodiments, some of the closed loop control elements may beimplemented in the endoscope and/or on an external system electricallycoupled to the element may be used in the cooling mode so as toimplement internal cooling rather than heating.

FIG. 4B illustrates one configuration of a heating element at the distalend of an endoscope sheath. The heating elements 410 may be positionedin the endoscope sheath body 420 at or near the distal end 122, or atother locations in the sheath body. The heating elements 410 aretypically used in an endoscopy procedure for providing heat to clear theoptical port 224 (or other sheath surfaces or elements not shown) tofacilitate improved imaging of the area under examination. It is alsonoted that, in some embodiments, cooling elements (not shown) configuredto provide a cooling function similar to that of the heating elements410 may also be used. Likewise, combination elements, such as Peltierjunction elements, may also be used to provide both heating and coolingfunctions in some embodiments. Power wires 415, or other powerdistribution channels, may be used to provide power to heating element410 from a connector element 435. Other associated elements, such as atemperature sensing element and associated power and wiring (not shown)may also be disposed in sheath 420 and used in conjunction with heatingelement 435 to monitor temperature or other conditions in the endoscopeand/or body area under diagnosis.

Attention is now directed to FIG. 5A which illustrates one embodiment ofa system 500 a for performing endoscopy using a sensor enhancedendoscope. System 500 a may include an endoscope 510, with the endoscopebeing enclosed for the procedure using a sensor enhanced endoscopesheath 220 or 320 (such as are as shown in FIG. 2 and FIG. 3), alongwith an optional signal conditioning module 520 and a processing storageand display module (“endoscopy analysis module”) 530. In typicalembodiments the endoscope 510 and sheath 220 or 230 are separatecomponents as described previously herein. However, as also notedpreviously, in some embodiments endoscope 510 may also include one ormore sensors incorporated into the endoscopy body.

In order to process signals received from the endoscope 510 and/or theendoscope sheath 220 or 320, signal conditioning module 520 includeselectronic circuitry for processing raw signals from the endoscopeand/or the sheath and converting the signals to a standardized formatfor input into module 530 for further analysis, processing, displayand/or storage of signals, images or other data. This conversion mayinclude analog-to-digital conversion, signal format conversion orencoding, image processing, or other signal conditioning or processing.Alternately, module 530 may be configured for direct input of the rawoutput signals from the endoscope 510 and/or the sheath 220 or 230, withthe signal conditioning module bypassed with respect to one or both ofthe endoscope and sheath outputs. System 500 a includes a displayelement 548, which may be an LCD, plasma or other display technology asare known or developed in the art. Module 530 may receive the sensorydata from sensor(s) 230 and may fuse this data with images received fromthe endoscope, with the fused sensor and image data then stored inmodule 530 or in another in another system (not shown). In addition,display 548 may be configured to provide a composite displaypresentation 549 as shown in FIG. 5A, where the image data, such as across section of an airway being imaged (as shown in FIG. 5A), is fusedwith the sensor data (in this example, pressure data P1-P4, temperaturedata T1, humidity data HT, as well as other sensory data (not shown) anddisplayed for use during a medical procedure or for future use. Inaddition, dimensional data 547, such as airway dimensions D1 and D2, maybe collected from the endoscope or endoscope sheath, associated andfused with the other sensory information and stored together, and may bedisplayed on a display such as display 548 as shown in FIG. 5A.

FIG. 5B illustrates additional details of one embodiment of an endoscopymodule 530 configured for receipt and processing of signals and datafrom a sensor enhanced endoscope system. Signals and data may includeanalog or digital sensory data, such as may be provided by the endoscopesheath and associated sensors and electronics, video or images as may beprovided by the endoscope or other instrument, as well as other dataand/or information such as may be provided by other sensors on apatient, or data or information from servers, databases or othersystems, such as x-ray images, MRI images, or other data or information.

In a typical embodiment, module 510 includes one or more input/output(I/O) devices 542 configured to receive and transfer data or signals toand from the endoscope 510 and sheath 220 or 320 either directly orthrough signal conditioning module 520, which may include analog I/Ofunctionality and/or digital I/O functionality. This may be done usingcircuits provided from companies such as Maxim, National Semiconductoras well as others. Module 530 may be configured to receive image orother visual data and fuse this data with the sensory data and or otherdata or information, such as clock or timing information.

Module 530 may also include one or more media drives 544 to receiveinput media data and information and provide media output (such as aread/write CD drive, DVD drive, Blu-Ray or other readable and writablemedia device). Module 530 may also include one or more processors 550configured to interface to other devices in module 530 and process, inaccordance with one or more sets of machine readable instructions storedon a machine readable medium, such as a memory, a hard disk, CD or DVD,RAM, ROM or other digital storage media.

Module 530 may also include one or more databases 560 configured tostore and provide data and information, such as text or graphics,images, videos, or other endoscopy related data or information. This mayinclude records or other information associated with one or morepatients undergoing endoscopy with system 530 along with associatedimages and sensory data. Additional elements of module 530 may includeone or more network connection modules configured to provide networkconnectivity to module 530, such as through Ethernet, Firewire, USB,wireless networking (such as via IEEE-802.11 (Wi-Fi), Wi-Max, Cellular)or other networking technologies.

Module 530 may also include one or more display interfaces 548, alongwith one or more displays (not shown) such as computer or video monitorsfor displaying the endoscopy results and/or associated sensor data.

Module 530 also includes one or more memory spaces 570 configured tostore one or more application program modules for facilitating receipt,processing, analysis, fusion, storage and retrieval of endoscopy images,data and associated sensory and other information such as is describedelsewhere herein. In a typical operation, the processor controls poweron of the endoscope and sheath sensors. This may be done in conjunctionwith a power control module 547 as shown in FIG. 5B. After power on whenthe endoscope, sheath instrumentation and any other data or informationis available, the processor may then control acquisition of video andimages from the endoscope, along with sensory data from the sheath, andfuse this information with any addition data or information, such astiming information, other sensory inputs, dimensional information,stored data or images, and the like. This information may then beaggregated and stored in the database 560 and/or memory 570. Inaddition, the information may then be displayed on a display device,such as is shown in FIG. 5A. The collected and fused information mayalso be stored on media using media drive 544.

Attention is now directed to FIG. 6A, which illustrated details of anendoscope sheath 620 a including a sensor 230 along with a positionlocation element 610. As described previously with respect to FIG. 3D,the position location element can be a magnetic element, a Hall effectsensor, a metallic element, or other position sensing element as knownor developed in the art. When used with the apparatus illustrated inFIG. 3D, the position location element may be used to identify aposition of a sheathed endoscope relative to patient body features orother areas being examined by endoscopy.

Attention is now directed to FIG. 6B, which illustrates an embodiment ofa sheath 620 b including a measurement element, in this case anultrasonic measurement element 625 Measurement element 625 may bedisposed in the sheath body relatively close to the distal end or sensorelement(s) 230 so as to make dimensional measurements associated withthe endoscopy images and sensory data collected by the endoscope system.For example, dimensional values 547 may be collected and mapped to orfused with data provided on an image display such as is shown as D1 andD2 in display element 548 of FIG. 5A.

Attention is now directed to FIG. 7 which illustrates one embodiment ofa process 700 for performing an endoscopy procedure, in accordance withaspects of the present invention. It is noted that process 700 includesparticular stages; however, these stages are shown for purposes ofillustration, not limitation. Other processes having more, fewer, ordifferent stages are also within the spirit and scope of the presentinvention. In addition, it is noted that one or more stages of process700 may be performed with an endoscopy system such as those illustratedin FIG. 2A through FIG. 6; however, other embodiments of the process 700may be performed with additional and/or different elements than thoseshown in the figures.

Turning to FIG. 7, process 700 may begin at a start stage 710, where anendoscope sheath, typically a sheath including one or more sensorelements such as shown in FIG. 2 and FIG. 3, with the sensors includingone or more pressure sensors, is positioned on the endoscope. In someembodiments an endoscope having embedded sensor, rather than sheathedsensors, may alternately be used. In either case, at stage 715, theendoscope is positioned in the patient's body at a desired location by amedical professional, such as a medical doctor. For example, it may bedesirable to position the sheathed endoscope in an airway, such as thenasal passage or the back of the throat, to observe airway restrictionsor other airway conditions. At the same time, other imaging devices,such as CT scams, X-ray imaging, MRIs, and/or other imaging technologiesmay optionally be used to further observe the airway and positioning ofthe sheathed endoscope during the procedure. It may be desirable to usethe imaging capabilities of targets or fiducials (such as fiducials 340shown in FIG. 3), or positional sensors (such as shown in FIG. 6A) tomonitor the position of the endoscope and/or specific sensors such assensors 320 or 330.

At stage 720, visual information is captured by the sheathed endoscope,along with one or more sensor measurements. The sensor measurements mayinclude sensor data such as pressure readings at one or more points inthe airway under observation. Likewise, other sensor readings, such asairflow, airway circumference, temperature, pH, or other parameters mayalso be measured simultaneously and/or sequentially with the endoscopeimaging visualizations and optional external imaging. At stage 725,location and/or positional information of the endoscope may bedetermined and/or registered alone or in conjunction with the otherimaging systems (such as by recording the positional information on a CTscan, MRI and the like). The information obtained by the sensor, as wellas any associated endoscope information or data, may then be transferredat stage 730 to the processing system, such as system 530 shown in FIG.5A and FIG. 5B. This may include transfer of the information obtained bythe sensor (and/or endoscope) to a signal conditioning module to bufferand/or condition the data obtained by the sensor(s) and/or endoscopebefore transferring it to system 530. When the data and information fromthe endoscope and sensor have been transferred to the processing system530 it may then be associated at stage 735, such as by storing theimages obtained by the endoscope with the associated sensor readings(such as pressure, PH, temperature, dimensional measurement, etc.),further processed, and/or analyzed. The received sensor and/or endoscopedata, along with any associated or processed data, may then be stored ina memory of the system 530 for further use.

FIG. 8 illustrates details of use of a smart sheath 820 disposed on anendoscope in conjunction with an endoscopy analysis module 810configured to fuse endoscopy imaging data with sensory data. Module 810may include multiple sub-modules, including an imaging module 832,configured to provide imaging data and/or display information from anendoscope imaging element, a communications module 834 configured tocommunicate data and/or other information from the smart sheath to othermodules or systems. A sensing module 838 may be included to receive andprocess sensor information from one or more sensor elements disposed inthe smart sheath, which may include temperate sensors, pressure sensors,PH or other chemical sensors, airflow sensors, conductivity sensors orother sensors as are known or developed in the art. A position module840 may be included, with the positioning module configured to determineposition based on information received from the smart sheath and/or aidin positioning the endoscope. The fused data may be stored in a memoryand/or provided to other modules or systems via the communication module834.

FIGS. 9A and 9B illustrates details of an embodiment of a smart sheathendoscopy system including a cross sectional sensor reading taken atpositions axially disposed around the smart sheath. In particular, asmart sheath may be configured with a plurality of sensor elements asshown in FIGS. 3B and 3C, with a corresponding pressure profile thendetermined and mapped to the body cavity under examination. The mappingmay be done in conjunction with imaging of the body cavity such as maybe done using an image element of the endoscope. Dimensionalinformation, such as D1 and D2, may be collected as described previouslyherein and associated with the pressure profile or other sensoryinformation, with the results being stored in a memory and/or displayedsuch as shown in FIG. 5A. During medical or other endoscopy procedures,the endoscope may be moved and the movement registered and associateddata collected, such as described previously with respect to FIG. 3D, ormay be collected at a fixed endoscope position, which may include datacollection from arrayed sensors such as shown in FIGS. 3A-3C.

In another aspect, in some embodiments a smart endoscope sheath mayinclude, in addition to one or more sensors, a leak detection mechanismconfigured to detect leaks in the body of a sheath. This may be done aspart of a sheath testing process and/or while use on an endoscope duringa medical procedure. Detected leaks may be indicated on a display, suchas display 548 as shown in FIG. 5A, and/or on an audible or visual alarmcoupled to the endoscope or sheath (now shown). In addition, dataassociated with the leak may be collected and stored in the endoscopeanalysis module or in other systems.

Turning to the figures, FIG. 10 illustrates an example of a leak 1030 ina sheath body (not to scale). A leak such as shown in FIG. 10 may exposethe endoscope and/or the patient under examination to contamination bypathogens, chemicals and the like. In non-medical procedures, a leak mayexpose an endoscope to similar contaminants, and/or to corrosives,toxins, etc. Consequently, it may be advantageous to incorporate leakdetection capabilities into the smart sheath and the associatedendoscopy system.

FIGS. 11A-11C illustrate details of one embodiment of a leak detectionapparatus for use with a smart sheath using electronic leak detectionsensing. A smart sheath 1120 may include one or more sensor elements230, and may further include a conductive material 1135 disposed on orin proximity to the inner surface of the sheath body 1125, within thecavity for receiving the endoscope. Alternately, or in addition, in someembodiments additional conductive material may be disposed on anexterior surface of the sheath body (not shown).

As shown in FIGS. 11B and 11C, the conductive material 1135 may bedisposed on all or most of the inner surface of the sheath to form anelectrode. The conductive material may be a material deposited or coatedon the inner surface of the sheath, and in some embodiments may be aconductive gel or similar material. Alternately, the conductive materialmay be a metallic coating or other conductive coating. In someembodiments, only a portion of the inner surface of the sheath may havethe conductive material deposited thereon. This may be, for example, ina grid or other pattern on part of the inner surface. The conductivematerial may be used in conjunction with a leak detection circuit todetect leaks in the endoscope sheath body.

FIG. 12A illustrates details of a leak detection apparatus includingmodule 1250 configured to detect a leak in a smart sheath body, alongwith a conductive material 1135 as shown in FIG. 11. In one exemplaryembodiment, module 1250, in conjunction with conductive material 1135,comprises a current flow or ion flow detection circuit, which may beimplemented using elements described herein or as shown in the patentspreviously incorporated herein. In an exemplary embodiment, when a leakoccurs, a conductive or partially conductive material, such as a salinebodily fluid, contact the conductive material, resulting in currentflow. The leak detection circuit may be configured to detect this flowand thereby sense a leak. Alternately, in some embodiments, othercircuits for electrical detection of leaks as are known or developed inthe art may be used.

FIG. 12B illustrates one embodiment of a leak detection circuit 1270that may be used in conjunction with the sheath 1120 for detection ofleakage. Leak detection circuit 1270 may be part of a leak detectionmodule such as module 1250 of FIG. 12A. In this implementation, theconductive material comprises an electrode that is coupled to thecircuit 1250 to detect current flow associated with a leak. Otherelectrically based leak detection circuits may also be used in variousembodiments. In some implementations, the sheath leak detectionapparatus comprises only the conductive material/electrode disposed onor in the sheath body. Alternately, in some embodiments the leakdetection apparatus may comprise the electrode and a circuit such ascircuit 1270, which may be on or connected to the sheath body.

FIG. 12C illustrates details of another embodiment wherein an additionalelectrical insulation layer 1145 is disposed between the conductivelayer 1135 and the cavity interior to the sheath. This configuration maybe useful when the endoscope exterior is a metallic or other conductivematerial.

FIG. 13 illustrated details of an alternately embodiment of a leakdetection apparatus using a pressure sensing element to providepneumatic leak detection sensing. The pressure sensing element may be apressure sensor 230 as shown in FIG. 13, which in some implementationsmay be common with or shared with the pressure sensing functionsdescribed previously herein. Alternately, the pressure sensing elementmay be a separate element. In some implementations, a flow sensor,rather than a pressure sensing element, may be used for pneumatic leakdetection. In either case, the sensing element is configured to detect asignal associated with a leak in the sheath body where air or liquidsare moving through the leak. To facilitate this, a sealing mechanism1325 is typically included at the proximal end of the sheath 1320. Thesealing mechanism may be an elastic element, an o-ring or other sealingelement, a clamp, or other sealing mechanisms known or developed in theart.

In addition, a pressure supply control module 1350 may be included toprovide a gas or liquid supply and associated gas or liquid pressure viaa pressure supply line 1330 to the space between the inner surface ofthe sheath 1320 and the endoscope 110. Module 1350 may be configured tosupply a source of gas pressure to the cavity between the inside of theendoscope sheath body and the exterior of the endoscope. Alternatelyand/or in addition, module 1350 may be configured with an airflow sensorto detect flow of a gas, such as may occur during a leak of the smartsheath. Leak detection may be determined by sensing a flow of gas orliquid out of the sheath and/or by monitoring pressure in the sheathcavity or by other pneumatic or hydraulic means.

Attention is now directed to FIGS. 14A and 14B which illustrate oneembodiment of an actuator apparatus incorporated in an endoscope sheath1420. In sheath 1420, the actuator apparatus is a balloon catheterassembly, with the sheath body configured to allow for deployment orretraction of a balloon element 1430 for performing a balloon proceduresuch as thermal, RF, acoustic, ultrasonic, optical or other ablationtreatments, or other balloon treatments such as expansion of a vessel orairway. The actuator may be controlled by an actuator control mechanism1450, with the mechanism configured to deploy, retract and/or otherwisecontrol the actuation element (e.g., the balloon element 1430). Controlmechanism 1450 may include mechanical and/or electronic elements tofacilitate control of the actuator.

FIG. 15 illustrates another embodiment of a sheath 1520 incorporating analternate balloon catheter element 1530. In this embodiment, theactuator balloon 1530 may be clear or transparent, in whole or part, soas to provide additional imaging capability through any endoscopeimaging elements at the distal end (not shown). Balloon 1530 may includelenses 1535 or other optical elements to further aid visualization ofimages collected by the endoscope. The actuator element on sheath 1520may be controlled by an actuator control element 1550.

FIGS. 16A and 16B illustrate another embodiment of a sheath 1620incorporating an alternate balloon configuration. In thisimplementation, the sheath body is configured so that balloon element1630 may be deployment from an area in the side of sheath 1620 near thedistal end.

FIGS. 17A and 17B illustrate another embodiment of a sheath 1720incorporating an actuator in the form of a surgical instrument 1730.Instrument 1730 may include one or more scalpel elements 1740 or othersurgical instrument as is known in the art. In this implementation,instrument 1730 is disposed in the sheath 1720 body and may be deployedor refracted as shown in FIGS. 17A and 17B. The actuator may becontrolled by a control module 1750, which may facilitate electrical,mechanical, pneumatic, or other control of the surgical instrument.

In some embodiments, multiple actuator apparatus may be included in thesheath. For example, in one implementation, a first actuator apparatusmay be a balloon catheter and a second actuator apparatus may be a stentplacement apparatus. Stent placement apparatus are known in the art andare described in, for example, U.S. Patent Publications 20070250157,20060276873, 20060200222, which are incorporated by reference herein, aswell as in various other patents and publications.

As used herein, the word “exemplary” means “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments, and is not intended to be limitingin any way unless otherwise noted.

Some aspects of the present invention may be embodied in the form orcomputer software and/or computer hardware/software combinationsconfigured to implement one or more processes or functions of thepresent invention as described and illustrated herein. These embodimentsmay be in the form of modules implementing functionality in software,firmware, and/or hardware/software/firmware combinations. Embodimentsmay also take the form of a computer storage product with acomputer-readable medium having computer code thereon for performingvarious computer-implemented operations, such as operations related tofunctionality as describe herein, on one or more computer processors.The media and computer code may be those specially designed andconstructed for the purposes of the present invention, or they may be ofthe kind well known and available to those having skill in the computersoftware arts, or they may be a combination of both.

Examples of computer-readable media within the spirit and scope of thepresent invention include, but are not limited to: magnetic media suchas hard disks, floppy disks, and magnetic tape; optical media such asCD-ROMs, DVDs and holographic devices; magneto-optical media; andhardware devices that are specially configured to store and executeprogram code and/or data, such as application-specific integratedcircuits (“ASICs”), programmable logic devices (“PLDs”) ROM and RAMdevices, Flash devices, and the like. Examples of computer code mayinclude machine code, such as produced by a compiler, and filescontaining higher-level code that are executed by a computer using aninterpreter. Computer code may be comprised of one or more modulesexecuting a particular process or processes to provide useful results,and the modules may communicate with one another via means known in theart. For example, some embodiments of the invention may be implementedusing Java, C#, C++, or other programming languages and softwaredevelopment tools as are known in the art. Other embodiments of theinvention may be implemented in hardwired circuitry in place of, or incombination with, machine-executable software instructions.

The claims are not intended to be limited only to the aspects shown inthe drawings and described previously herein, but are to be accorded thefull scope consistent with the language of the claims, wherein referenceto an element in the singular is not intended to mean “one and only one”unless specifically so stated, but rather “one or more.” Unlessspecifically stated otherwise, the term “some” refers to one or more. Aphrase referring to “at least one of’ a list of items refers to anycombination of those items, including single members. As an example, “atleast one of: a, b, or c” is intended to cover: a; b; c; a and b; a andc; b and c; and a, b and c.

The foregoing description, for purposes of explanation, uses specificnomenclature to provide a thorough understanding of the invention.However, it will be apparent to one skilled in the art that specificdetails are not required in order to practice the invention. Thus, theforegoing descriptions of specific embodiments of the invention arepresented for purposes of illustration and description, not limitation.They are not intended to be exhaustive or to limit the invention to theprecise forms disclosed; obviously, many modifications and variationsare possible in view of the above teachings. The embodiments were chosenand described in order to best explain the principles of the inventionand its practical applications, they thereby enable others skilled inthe art to best utilize the invention and various embodiments withvarious modifications as are suited to the particular use contemplated.It is intended that the following claims and their equivalents definethe scope of the invention.

The invention claimed is:
 1. A system for evaluating an airway, thesystem comprising: an endoscopy sheath having plural pressure sensorsconfigured about and positioned on the external surface of the endoscopysheath so that the plural pressure sensors are capable of providingpressure data related to the airway from more than one cross-sectionalposition about the endoscopy sheath; an endoscope for disposition withinthe endoscopy sheath, the endoscope for providing image data of theairway; a visual display; and an endoscopy analysis module configured toreceive the pressure data related to the airway and the imaging data ofthe airway, the endoscopy analysis module comprising a processor, a datafusion module and a display module, the endoscopy analysis module beingconfigured to provide information to the visual display in which theimage data and the pressure data related to the airway are associated sothat the visual display depicts, in one image, image data of the airwayand pressure data related to the airway at more than one cross-sectionalposition about the image data of the airway.
 2. The system of claim 1further comprising a temperature sensor positioned on the externalsurface of the endoscopy sheath.
 3. The system of claim 1 furthercomprising a pH sensor positioned on the external surface of theendoscopy sheath.
 4. The system of claim 1 in which the endoscopyanalysis module further comprises a position sensing module.
 5. Thesystem of claim 1 in which the endoscopy analysis module is configuredto receive the pressure data and the image data via wires.
 6. The systemof claim 1 in which the endoscopy analysis module is configured toreceive the pressure data and the image data by radio frequency.